SUMMARY OF PRODUCT CHARACTERISTICS (SPC)...SUMMARY OF PRODUCT CHARACTERISTICS (SPC) Hyperidrine...

SUMMARY OF PRODUCTCHARACTERISTICS (SPC)

HyperidrineSummary of Product Characteristics

Bio-Health Ltd. Culpeper Close, Medway City Estate, Rochester, Kent ME2 4HUt +44 (0)1634 290 115 f +44 (0)1634 290 761 e [email protected] w www.bio-health.co.uk



- SECTION 1 - NAME OF THE MEDICINAL PRODUCT

HYPERIDRINE Capsules

- SECTION 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 300mg of St John’s Wort aerial parts (Hypericum perforatum L.)For full list of excipients see section 6.1.

- SECTION 3 - PHARMACEUTICAL FORM

Hard capsules.Clear size 0 hard capsules.

- SECTION 4 - CLINICAL PARTICULARS

- SECTION 4.1 - Therapeutic Indications

Hyperidrine is a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only.

- SECTION 4.2 - Posology and method of administration

For oral short term use only. Adults and the Elderly: Take one capsule three times a day, swallowed with water. The patientshould consult a doctor or qualified healthcare practitioner if symptoms worsen or do not improve after 6 weeks. Not recommended for children or adolescents under 18 years (See Section 4.4 Special warnings and precautions for use).

- SECTION 4.3 - Contra-indications

Hypersensitivity to St John’s Wort or any of the excipients.

Hyperidrine should not be used in patients with known dermal photosensitivity or those undergoing phototherapy or any photodiagnostic procedures.

Hyperidrine should not be taken concomitantly with any of the medicines specified in section 4.5. This is because St. John’s wort (Hypericum performatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines including a possible decrease in the effectiveness of those medicines.

Pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and the triptan group of medicines.

- SECTION 4.4 - Special Warnings and Precautions for Use

Do not exceed the stated dose.

The use of Hyperidrine is not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

If the condition worsens or if symptoms persist for more than 6 weeks medical advice should be sought.

Hyperidrine is intended for the relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should consult a doctor for appropriate treatment.

In very rare cases, particularly in fair-skinned individuals, sunburn type reactions may occur on skin areas exposed to strong sunlight due to photosensitisation by St. John’s Wort. Patients taking Hyperidrine should avoid excessive sunbathing or the use of sunbeds or solariums.

Hyperidrine should be discontinued at least 10 days prior to elective surgery due to the potential for St.John’s Wort to interact with drugs used during general and regional anaesthesia.



CO-ADMINISTERED DRUG INTERACTION RECOMMENDATIONS CONCERNINGADMINISTRATION

Anaesthetic/pre-operative medicines

Fentanyl,propofol,sevoflurane,midazolam

Reduced blood levels withrisk of therapeutic failure.

Based on the elimination half-lives of Hypericumand hyperforin this product should bediscontinued at least 10 days prior to surgery.

Analgesics

Tramadol Reduced blood levels withrisk of therapeutic failure.

Do not take with this product.

Antianginals

Ivabradine Reduced blood levels withrisk of therapeutic failure.


Anti-arrhythmics

Amiodarone Reduced blood levels withrisk of therapeutic failure.


Antibacterials

Erythromycin,clarithromycin,telithromycin



Anticoagulants

Warfarin,acenocoumarol

Reduced anticoagulanteffect and need forincreased dose.


Continued...

- SECTION 4.5 - Interaction with other medicaments and other forms of interaction

Substances in St John’s Wort (Hypericum perforatum) have been shown to induce Cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of those medicines.

The concomitant use of ciclosporin, tacrolimus for systemic use, amprenavir, indinavir and other protease inhibitors, irinotecan and warfarin is contraindicated

Special care should be taken in case of concomitant use of all drug substances the metabolism of which is influenced by CYP1A2, CYP3A4, CYP2C9, CYP2C19 or P - glycoprotein (e.g. amitriptyline, fexofenadine, benzodiazepines, methadone, simvastatin, digoxin, finasteride), because a reduction of plasma concentration is possible.

Users of oral contraceptives taking St John’s Wort (Hypericum perforatum) may experience intracyclic menstrual bleeding and risk of contraception failure is increased.

Clinically significant pharmacodynamic interactions have also been identified with the SSRI antidepressants and the triptan group of medicines used to treat migraines. Due to the increased risk of undesirable effects associated with these interactions this product should not be used concomitantly with these types of Medicines.

Therefore, Hyperidrine (St John’s Wort) should not be taken concomitantly with the Medicines includedin the following table.



Antidepressants

Tricyclics eg:amitriptyline,clomipramineMAOIs egMoclobemideSSRIscitalopramescitalopramfluoxetinefluvoxamineparoxetinesertralineOthers egduloxetinevenlafaxine

Increased serotonergiceffects with increasedincidence of adversereactions.


Antiepileptics

All drugs in this class including:carbamazepinephenobarbitonephenytoinprimidonesodiumvalproate

Reduced blood levels withincreased risk of frequencyand severity of seizures.


Antifungals

Itraconazolevoriconazole



Antimalarials

Artemetherlumefantrine



Anti-parkinsons

Rasagiline Reduced blood levels withrisk of therapeutic failure.


Antipsychotics

Aripiprazole Reduced blood levels withrisk of therapeutic failure.


Continued...

Antivirals

HIV protease inhibitors:amprenaviratazanavirdarunavirfosamprenavirindinavirlopinavirnelfinavirritonavirsaquinavirtipranavir

Reduced blood levels withpossible loss of HIVsuppression.


HIV non-nucleoside reversetranscriptase inhibitors:efavirenznevirapinedelavirdine

Reduced blood levels withpossible loss of HIVsuppression.




CNS Stimulants

Methyl phenidate Reduced blood levels withrisk of therapeutic failure.


Cytotoxics

Irinotecandasatiniberlotinibimatinibsorafenibsunitinibetoposidemitotane



Hormonal contraceptives

Oral contraceptives

Emergency hormonalcontraception

Hormonal implants,injections

Transdermal patches,creams etc

Intra-uterine devices withhormones

Reduced blood levels witha risk of unintendedpregnancy andbreakthrough bleeding.


Continued...

Barbiturates

Butobarbitalphenobarbital



Calcium channel blockers

Amlodipinenifedipineverapamilfelodipine



Cardiac glycosides

Digoxin Reduced blood levels andloss of control of heartrhythm or heart failure.


Anxiolytics

Buspirone Increased serotonergiceffects with increasedincidence of adversereactions.


Aprepitant Reduced blood levels withrisk of therapeutic failure.


Hormone Replacement Therapy

Hormone replacementtherapy: oral transdermalpatches, gels vaginal rings



Hormone antagonists

Exemestane Reduced blood levels withrisk of therapeutic failure.


- SECTION 4.6 - Pregnancy and Lactation

The safety of Hyperidrine (St John’s Wort) during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.

- SECTION 4.7 - Effects on ability to drive and use machines

No adequate studies on the effect on the ability to drive and use machines have been performed.



Diuretics

Eplerenone Reduced blood levels withrisk of therapeutic failure.


5HT agonists

Alomotriptaneletriptanfrovatriptannaratriptanrizatriptansumatriptan andzolmitriptan

Increased serotonergiceffects with increasedincidence of adversereactions.


Immunosuppressants

Ciclosporintacrolimus

Reduced blood levels with arisk of transplant reaction.


Lipid regulating drugs

Simvastatinatorvastatin

Reduced blood levels with arisk of therapeutic reaction.


Lithium Reduced blood levels with arisk of therapeutic reaction.


Proton pump inhibitors

Lansoprazoleomeprazole

Reduced blood levels with arisk of therapeutic reaction.


Theophylline Reduced blood levels andloss of control of asthma orchronic airflow limitation.


Thyroid hormones

Thyroxine Reduced blood levels with arisk of therapeutic reaction.


Oral hypoglycaemic drugs

Gliclazide Reduced blood levels with arisk of therapeutic reaction.




- SECTION 4.8 - Undesirable effects

Gastrointestinal disorders including dyspepsia, anorexia, nausea, diarrhoea or constipation; allergic skin reactions such as rash, urticaria, pruritis; fatigue and restlessness have been reported.The frequency is not known.

Fair-skinned individuals may react with intensified sunburn-like symptoms under intense sunlight or strongultra-violet (UV) irradiation.

Other adverse reactions that have been reported include headaches, neuropathy, anxiety, dizziness and mania.

If other adverse reactions not mentioned above occur, a doctor, pharmacist or a qualified healthcarepractitioner should be consulted.

- SECTION 4.9 - Overdose

No cases of overdose have been reported.

After the intake of up to 4.5g dry extract per day for 2 weeks and additionally 15g dry extract just before hospitalisation seizures and confusion have been reported.

When a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for 1-2 weeks from UV irradiation and sunlight. Outdoor activities should be restricted and clothes and/or sun block preparations used to protect the skin from sunlight. Symptomatic and supportive measures should be takenas appropriate.

- SECTION 5 - PHARMACOLOGICAL PROPERTIES

- SECTION 5.1 - Pharmacodynamic Properties

Pharmacotherapeutic group: Herbal medicinal product for treatment of depressive disorders.

ATC Code: N06AX

The active constituents of Hyperidrine (St John’s Wort) have not been definitively established. However, hypericin, pseudohypericin hyperforin and the flavonoids are considered to have synergistic activity.

- SECTION 5.2 - Pharmacokinetic Properties

No definitive pharmacokinetic data available.

The active ingredients of Hyperidrine (St John’s Wort) can interact with other medicinal agents in two ways. Firstly, active ingredients in Hyperidrine (St John’s Wort) themselves are metabolised in the liver by the CYP3A isoenzymes, increase (induce) the activity of this enzyme so that it accelerates the elimination of other medicinal agents which are degraded by the same pathway. This leads to a consequent reduction in the plasma concentration and effectiveness of these other substances. Secondly, the active ingredients in Hyperidrine (St John’s Wort), like othertype SRI or SSRI medicinal agents with an antidepressant action, can raise the concentration of serotonin in certain parts of the central nervous system so that this neurotransmitter can sometimes reach toxic levels, particularly when drugs containing St John’s Wort are combined with other antidepressants.

- SECTION 5.3 - Preclinical safety data

Tests on reproductive toxicity and carcinogenicity have not been preformed. Adequate information is currently not available on genotoxicity.

Phototoxicity:After oral application of dosages of 1800mg of an extract per day for 15 days the skin sensitivity against UVA was increased and the minimum dose for pigmentation was significantly reduced. In the recommended dosage, no signs of photoxicity are reported.



- SECTION 6 - PHARMACEUTICAL PARTICULARS

- SECTION 6.1 - List of excipients

Hypromellose (Capsule shell).

- SECTION 6.2 - Incompatibilities

Not Applicable.

- SECTION 6.3 - Shelf-life

The shelf life of Hyperidrine is 3 years.

- SECTION 6.4 - Special Precautions for storage

Store below 25°C in the original packaging.

- SECTION 6.5 - Nature and contents of container

Duma 110ml HDPE plastic bottle and tamper evident threaded Duma cap.Duma 200ml HDPE plastic bottle and tamper evident press on Duma cap.

Hyperidrine pack contains 60 or 120 Capsules.

- SECTION 6.6 - Special precautions for disposal

There are no special precautions for disposal of Hyperidrine capsules. When the container is empty the label should be removed and the bottle placed in a recycling bin.

- SECTION 7 - MARKETING AUTHORISATION HOLDER

Bio-Health LimitedCulpeper CloseMedway City EstateRochesterKentME2 4HU

- SECTION 8 - MARKETING AUTHORISATION NUMBER(S)

THR 15817/0006

- SECTION 9 - DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29/09/2010

- SECTION 10 - DATE OF REVISION OF THE TEXT

29/09/2010

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)...SUMMARY OF PRODUCT CHARACTERISTICS (SPC) Hyperidrine...

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